IT Compliance Advisor 2

Job Description Summary

• Compliance and Validation

• Hands-on experience in the role of Compliance and Validation
• Well-versed with GxP, GDPR, FDA, Part 11, and standard regulations
• Knowledge of 21 CFR part 11, GxP regulations, GAMP 5 guidelines
• System validation in alignment with GxP and regulatory requirements
• Good knowledge of assessing Traceability gaps, improper verification of requirements, improper attached evidences, and raised observations for each deviation
• Hands-on experience in reviewing validation artifacts, and quality reviews

• System Life Cycle and Methodologies

• Well-versed with System Life Cycle
• Hands-on experience with Validation approach, Agile methodology, AIML concepts

• Testing/Validation Experience

• Exposure in reviewing Test Plans, Test Summary Reports
• Development of System Validation Lifecycle documents
• Risk Analysis, Validation Plan, Validation Summary Report
• Preparation and Review of validation deliverables (Validation plan, Functional Risk Assessment, Requirement Traceability Matrix, Qualification Summary Report)
• Good knowledge about the defect life cycle

• Tools and Technologies - Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems
• Quality Management - Knowledge of Quality Management System (QMS)
• Domain Knowledge - Healthcare, CRO, Life Sciences domain knowledge

Good to Have Skills :

• SaaS Validation and Process -Familiarity with SaaS validation and process
• System Validation
  • Analysis and development of System Validation Lifecycle documents
  • Risk Analysis of system and requirements.
• Compliance and Audits - IT and CSV compliance and audit of third-party vendors, Participation in internal audits and/or regulatory audits to represent CSV and IT compliance.
• Vendor Management - Vendor evaluation and qualification
• Testing/Validation Process - Knowledge about Testing/Validation process, automation
• Software Development Life Cycle (SDLC) - Good knowledge about the SDLC process
• Data Management and Risk-Based Approach - Good knowledge on data management, risk-based approach
• Documentation - Experience in authoring and improving SOPs, work instructions, and templates

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com